Gavel and stethoscope.

Long COVID and Physical Reductionism

By Leslie Francis and Michael Ashley Stein

Like plaintiffs with other conditions lacking definitive physiological markers, long COVID plaintiffs seeking disability anti-discrimination law protections have confronted courts suspicious of their reports of symptoms and insistent on medical evidence in order for them to qualify as “disabled” and entitled to statutory protection.

We call this “physical reductionism” in disability determinations. Such physical reductionism is misguided for many reasons, including its failure to understand disability socially.

Ironically, these problems for plaintiffs may be traced to amendments to the Americans with Disabilities Act (ADA) that were intended to expand coverage for plaintiffs claiming disability discrimination. Three provisions of the Americans with Disabilities Act Amendments Act (ADAAA) are appearing especially problematic for long COVID patients in the courts.

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USB drive

The False Dilemmas of the Fifth Circuit’s HIPAA Ruling

By Leslie Francis

In a caustic opinion issued on January 14, the Fifth Circuit vacated penalties assessed by the U.S. Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center for HIPAA security breaches.

As has happened to many other health care entities, M.D. Anderson had employees who were not careful with their laptops and thumb drives (and the data therein). A laptop with the unencrypted protected health care information of nearly 30,000 patients was stolen. Unencrypted thumb drives with information on another almost 6,000 patients were lost. M.D. Anderson disclosed the security breaches to HHS, which assessed civil monetary penalties for violation of HIPAA’s encryption and disclosure rules. M.D. Anderson then filed a petition for review, which resulted in the Fifth Circuit holding that the agency action was arbitrary and capricious for failure to consider an important aspect of the problem.

Commentators have already pointed out that this decision will reverberate throughout the HIPAA enforcement world. As it does, I hope it is met with scorn, for it trades on the informal logical fallacy of the false dilemma in two noteworthy ways.

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cruise ship

Old and New Ways of Coping with COVID-19: Ethics Matters (Part I)

By Leslie Francis and Margaret Pabst Battin

This post is part I of a two-part series on pandemic control strategies in response to COVID-19.

Your life and the lives of many others may depend now on isolation, quarantine, cordon sanitaire, shelter in place, or physical distancing.

These terms have entered the public consciousness rapidly. Though general awareness has increased, the important practical and ethical differences between these practices require further explanation.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Controlling the Novel Coronavirus: Should we have stopped the COVID-19 coronavirus more effectively? Could we still?

By Margaret Battin, Leslie Francis, Jay Jacobson, and Charles Smith

What if, instead of closing airports, shutting down trains and buses, quarantining travelers from China, and enclosing 50 million people inside the city of Wuhan and Hubei province, we had a sophisticated technology that could identify travelers who might spread an emerging infectious disease? This question is not hypothetical. We do have an available technology: polymerase chain reaction (PCR) rapid testing, one among several forms of nucleic acid amplification technology.

But PCR rapid testing has been deployed imperfectly at best, especially in the United States. The initial case of what is thought to have been community transmission in the United States was not tested for several days. The result was preventable exposures to infection of health care workers and potentially others. Testing criteria were set very narrowly. Rapid test kits designed by CDC did not work successfully because of problems with one of the reagents. On February 29, the FDA issued guidance allowing laboratories CLIA-certified for high complexity testing to use tests they had developed and validated before receiving emergency use approval.

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phone camera

More perils of U.S. sectoral privacy law

By Leslie Francis

A recent unpublished decision of the Minnesota Court of Appeals brings the perils of sectoral privacy law into sharp focus: Furlow v. Madonna Summit of Byron, 2020 WL 413356 (Minn. App. 2020) (unpublished).  Minnesota protects patient health records but not, apparently, photographs of patients posted on social media by health care facility staff.

V.F. was a patient at Madonna Summit of Byron, a senior living facility with independent living, assisted living, and memory care units. Jane Doe was a nursing assistant at Madonna. After V.F. pulled a fire alarm, annoying Jane, Jane snapped a photograph of V.F. and posted it on her personal social media page.  Jane captioned the photo: “This little sh-t just pulled the fire alarm and now I have to call 911!!! Woohoo.” The photo contained no further identifying information.  It didn’t name V.F., say where she lived, or identify Jane Doe or where she worked. It was, however posted on Jane Doe’s personal account, thus identifying Jane Doe to those with access to her account. V.F.’s personal representative sued for damages under the Minnesota Health Records Act. The Minnesota Court of Appeals upheld dismissal of the complaint, concluding that the social media post was not release of a “health record” under Minnesota law. Read More

Picture of doctor neck down using an ipad with digital health graphics superimposed

Practice Fusion: it’s data use, not de-identification, that matters

By Leslie Francis

Practice Fusion, an electronic health record (EHR) vendor, just settled with the Department of Justice to pay a $145 million fine for alleged kickbacks from an unnamed pharmaceutical company.  The DOJ contended that the company had taken kickbacks in exchange for including practice alerts to encourage physicians to prescribe opioids.  But paid-for prescription alerts were not the only practices engaged in by Practice Fusion with de-identified patient data.

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Call for Papers: Law and Society Association Law and Health CRN

As a scholar working in health law and bioethics, a persistent concern of mine has been the somewhat limited connections between those fields and scholars in the social sciences, particularly political science, economics, and sociology.

Perhaps the best venue for interchange among the social sciences and law may be less well known among folks in health law and bioethics than it should be (at least to judge from inquiries I received when I posted a recent call for papers on the mcw bioethics listserv): the Law and Society Association (LSA).

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Making “Meaningful Access” Meaningful: Equitable Healthcare for Divisive Times

By Leslie Francis

Another anniversary of President Bush’s signing of the Americans with Disabilities Act (ADA) is coming up in late July, yet the nation remains far from offering even a semblance of equitable societal opportunity to most individuals with disabilities.

For them, full social participation is dismissed as merely an idealistic dream. With its focus on restoration of full functioning for patients, the health care delivery system might be supposed an exception, but a closer look shows the opposite is true.

Physicians’ offices, clinics, and hospitals too often have not been made accessible. Too frequently, these facilities have diagnostic or treatment equipment that some people, due to disability, cannot use. Health care provider staff are not trained to interact with or assess disabled individuals, and may be swayed by implicit biases that target disability, just as are non-medical personnel or laypersons in the population.

disability rights protest sign
Photo by The Leadership Conference on Civil and Human Rights/Flickr

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Privacy and Confidentiality: Bill of Health at Five Years and Beyond

In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information.  The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection and use of health information for public health and research, commercialization and monetization of information, whether and why we care about health privacy, and much more.  Interestingly, Bill of Health has no categorizations for core concepts in this area:  privacy, confidentiality, security, health data, HIPAA, health information technology—the closest is a symposium on the re-identification of information, held in 2013.  Yet arguably these issues may have a significant impact on patients’ willingness to access care, risks they may face from data theft or misuse, assessment of the quality of care they receive, and the ability of public health to detect emergencies.

Over the past five years, Bill of Health has kept up a steady stream of commentary on privacy and privacy-related topics.  Here, I note just a few of the highlights (with apologies to those I might have missed—there were a lot!) There have been important symposia:  a 2016 set of critical commentaries on the proposed revisions of the Common Rule governing research ethics and a 2013 symposium on re-identification attacks.  There have been reports on the privacy implications of recent or proposed legislation: the 21st Century Cures Act, the 2015 proposal for a Consumer Privacy Bill of Rights, and the proposed Workplace Wellness Bill’s implications for genetic information privacy.  Many comments have addressed big data in health care and the possible implications for privacy.  Other comments have been highly speculative, such as scoping out the territory of what it might mean for Amazon to get into the health care business. There have also been reports of research about privacy attitudes, such as the survey of participants in instruments for sharing genomic data online.  But there have been major gaps, too, such as a dearth of writing about the potential privacy implications of the precision medicine and million lives initiative and only a couple of short pieces about the problem of data security.

Here are a few quick sketches of the major current themes in health privacy and data use, that I hope writers and readers and researchers and most importantly policy makers will continue to monitor over the next five years (spoiler alert: I plan to keep writing about lots of them, and I hope others will too): Read More